US Supreme Court delays abortion drug ruling

The US supreme court has once again pushed back a decision on whether to halt the suspension of decades-old authorisation for a drug used in more than half of the country’s abortions.

Justice Samuel Alito issued a brief order on Wednesday extending a deadline for the high court to act on the Department of Justice’s request to keep the abortion drug available while the underlying litigation runs its course. The new deadline is set for Friday. The move is the latest twist in a legal battle over the regulatory approval of abortion pills containing mifepristone, which has plunged abortion care into further disarray.

Earlier this month Matthew Kacsmaryk, a federal judge in Texas, overturned regulatory approval of mifepristone granted more than 20 years ago, in effect leading to a nationwide ban. He also ordered restrictions on the drug’s usage including stopping patients from receiving the pills by mail.

The fifth US circuit court of appeals put parts of the ruling on hold temporarily. However, the appeals court refused to block other parts of the decision that in effect re-established limitations on the distribution of mifepristone that had been gradually loosened by the Food and Drug Administration (FDA) since 2016.

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The justice department subsequently asked the supreme court to intervene and preserve access to the drug. Mr Alito last week issued a temporary stay on the Texas ruling until Wednesday, giving the supreme court more time to weigh the appeal.

The case was originally brought by anti-abortion groups aiming to block access to the drug, which is used in more than half of terminations in the US. It comes as the battle over abortion rights in the country intensifies after the supreme court last year dramatically overturned Roe vs Wade, a decision that had enshrined the constitutional right to abortion for nearly five decades.

Danco Laboratories, one of the main manufacturers of abortion pills containing mifepristone, has warned the restrictions would cause regulatory chaos and may force it to halt operations.

“The Fifth Circuit’s order, standing alone, will irreparably injure Danco,” the company said in a petition asking the supreme court to lift the restrictions. “The result is a regulatory mess that will ... [make] it exceedingly difficult, if not impossible, for Danco to continue selling its only product.”

More than 700 executives working in the pharmaceutical sector signed an open letter calling for the reversal of Kacsmaryk’s decision, which they argued “ignores decades of scientific evidence and legal precedent”.

In its filing with the supreme court, the department of justice also noted that the “FDA faces an obvious threat of irreparable harm from conflicting court orders”. Just minutes after the Texas decision, a district court in Washington state issued a contradictory ruling ordering the FDA to maintain the drug’s availability. Last week, it said the decision should be followed “irrespective” of the Texas ruling.

In advance of the supreme court’s decision, GenBioPro, the maker of a generic version of abortion pills containing mifepristone, filed a lawsuit seeking to ensure it could continue to sell its pill amid the continuing legal battles.

GenBioPro asked the court to order the FDA to keep the drug on the market, arguing that the agency was required to follow legal processes before taking action to alter the approval or availability of a drug.

– Copyright The Financial Times Limited 2023